Predictive Value of 99mTc- Albumin Spheres Before 90Y- SIR Therapy

Phase 2

Completed

• Conditions: Colorectal Cancer; Liver Metastases
• Interventions: Drug: MAA for diagnostic SPECT imaging; Drug: Diagnostic B20- SPECT imaging.

• Registration Number: NCT01186263
• Lead Sponsor: University of Magdeburg

Brief Summary

The purpose of this study is to assess the predictive value of 99mTechnetium (Tc)- labeled albumin in macroaggregates (MAA) and in microspheres (B20) injected into the common hepatic artery for the distribution of 90Yttrium- Selective Internal Radiotherapy (SIRT)-spheres (SIR- spheres).

Detailed Description

Patients with metastases of colorectal tumors will be included into this study provided that they are scheduled for 90Y SIR spheres therapy for clinical reasons. Before 90Y SIR spheres therapy, patients will receive a diagnostic examination with injection of MAA (group A) or B20 (group B) into the common hepatic artery to rule out a relevant shunt volume to the lung or other extra-hepatic locations (e.g., stomach) as recommended by the manufacturer. After the diagnostic scan, therapy with SIR- spheres will be conducted in 2 separate sessions with selective injection of 90Y labeled SIR spheres into the right and left hepatic artery at two separate occasions (routine procedure at the University of Magdeburg, Germany). In addition, therapeutic sessions will include the selective injection of MAA or B20 into the right / left hepatic artery according to a predefined plan (either alone or as a mixture with the SIR spheres).The intra-hepatic distribution of 90Y labeled SIR spheres will be assessed using "Bremsstrahlen"- Single- Photon- Emission- Computed- Tomography (SPECT)- imaging, the distribution of MAA and B20 will be assessed using SPECT imaging.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-23
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Primary Completion: 2011-07
• Study Completion: 2013-08
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-03
• Last Update Posted: 2014-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• age: between 18 and 85 years
• if female, postmenopausal or surgically sterilized
• liver metastases of a colorectal tumor in both liver lobes
• scheduled for therapy with 90Y SIR spheres for clinical reasons
• life expectancy longer than 6 months
• willing and able to undergo all study procedures
• having voluntarily provided written and fully informed consent

Exclusion Criteria

• presenting with a contraindication to 90Y SIR spheres therapy
• variants of the arterial hepatic blood supply which interfere with the objectives of this study (e.g., variants of Michel)
• women who are pregnant, lactating or who are of childbearing potential
• patients being clinically unstable
• uncooperative, in the investigator's opinion
• any contraindication to SIRT treatment
• any concomitant chemotherapy
• shunt to the lung >10%
• shunt to any extrahepatic organ (except the lung)
• having been previously enrolled in this study
• participating in another prospective clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
99mTc- labeled albumin macroaggregates (MAA)	MAA for diagnostic SPECT imaging	Diagnostic MAA- SPECT- imaging.
99mTc- labeled albumin microspheres (B20)	Diagnostic B20- SPECT imaging.	Diagnostic B20- SPECT- imaging.

Primary Outcome Measures

Name	Time	Method
Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m MAA scintigraphy	Tc-99m MAA scan one day prior to radioembolisation; Bremsstahlen-Scan after SIR spheres therapy	The percentage in liver volume for which the accumulation of SIR spheres during therapy was correctly predicted by Tc-99m MAA will be given by a blinded reader in categories by visual assessment (0-10%, \>10-20%, \>20-30%, ..., \>90-100%) (only patients who received Tc-99m MAA during evaluation.)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of the intrahepatic distribution of MAA and B20.	One day prior to SIRT	elimination half-life calculated in \[min\] from the decay-corrected radioactivity concentration measured over the liver; % radioactivity trapped in the liver at the individual measuring time points (of total radioactivity measured over the liver in the first scan); percent lung shunt (percentage of liver activity leaking to the lung at the individual time points)
Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m B20 scintigraphy	Tc-99m B20 scan one day prior to radioembolisation; Bremsstahlen-Scan after SIR spheres therapy	The percentage in liver volume for which the accumulation of SIR spheres during therapy was correctly predicted by B20 will be given by a blinded reader in categories by visual assessment (0-10%, \>10-20%, \>20-30%, ..., \>90-100%) (only patients who received Tc-99m B20 during evaluation.)
Adverse events as elicited upon indirect questioning.	At any visit.	Number of patients with adverse events (AEs), number of AEs per patient; descriptive listing of all AEs

Trial Locations

Locations (1)

Clinic for Radiology and Nuclear Medicine; 🇩🇪 Magdeburg, Sachsen-Anhalt, Germany